(i) Medicines including products of chemical or biological origin which are intended to have a medical effect on human or animal organisms, or which are presented as such, and which serve namely to diagnose, prevent or treat diseases, injuries or disabilities; blood and blood products are considered as medicines (relevant tariff items: 3002, 3003, 3004). (ii) Medical devices including products such as instruments, apparatus, equipment, in-vitro diagnostics, software, implants, reagents, material and other articles or substances which are intended for medical use, or which are presented as such, and which do not achieve their principal action through medicines (relevant tariff items: 3006, 9001.3000, 9001.4000, 9001.5000, 9003, 9004, 9018-9021)

Projet d'acte modificateur de la loi fédérale sur les médicaments et les dispositifs médicaux (Loi sur les produits thérapeutiques, LPTh) (Draft Act amending the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, LPTh)) (12 pages, available in French, German and Italian)

The European Union has adopted two new regulations: one on medical devices, and the other on in-vitro diagnostic devices. It aims to improve the quality and safety of medical devices, to harmonize the implementation of legislation in the EU, and thereby increase the safety of patients. In the context of the partial revision of the Law on Therapeutic Products, the legislation relating to the regulation of medical devices has been redrafted and adapted to the new EU legislation. The partially revised law establishes, inter alia, the obligations for economic operators and the adapted requirements for medical devices, the conformity assessment procedure, and the registration and identification of products that must be brought into line with the corresponding EU provisions (the regulation on medical devices and the regulation on in-vitro diagnostic devices). In parallel, the legislation in force regarding medical devices has been reviewed in terms of existing measures, and adapted where necessary.